UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective observational study to evaluate direct acting antivirals combination therapy for chronic hepatis C.
Title of the study (Brief title)	A prospective observational study to evaluate DAAs combination therapy for chronic hepatis C.
Region	Japan

Condition
Condition	chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of DAAs combination therapy for chronic hepatitis C prospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of patients with a sustained virological response 24 weeks after end of treatment (SVR24).
Key secondary outcomes	(1)Level of AFP and PIVKAII (2)Relation of HCC development (3)The percentage of patients with a sustained virological response 12 weeks after end of treatment (SVR12) (4)The percentage of patients whose serum HCV-RNA is undetectable at weeks 1, 2, 4, 8, 12, 16, 20, 24, 36, and 48 (5)The percentage of relapses (6)The percentage of patients with viralbreakthrough. (7)Level of FIB-4 index, other biological markers (8)Comparison with control group. (9)Relationship between IL28B genotype, IFNlambda4 genotype, HCV core mutation and efficacy.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients infected with hepatitis C virus genotype 1 2)Without HCC when participation 3)At least 20 years old when consent is given 4)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria	1)Women of childbearing potential during this study 2)Using interferon and ribavirin during this study 3)Using medicine on a CYP3A4 inducer or contraindicated to combination listed in an attached document 4)Evidence of hepatic decompensation (Child-Pugh classification B or C). 5)Otherwise found ineligible as a subject by the researcher
Target sample size	1000

Research contact person
Name of lead principal investigator	Akito Nozaki
Organization	Yokohama City University Medical Center
Division name	Department of Transfusion Medicine, Gastroenterological Center
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-261-5656
Email	akino@yokohama-cu.ac.jp

Public contact
Name of contact person	Akito Nozaki
Organization	Yokohama City University Medical Center
Division name	Department of Transfusion Medicine, Gastroenterological Center
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL	045-261-5656
Homepage URL
Email	akino@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学附属市民総合医療センター（神奈川県） 横浜市立大学附属病院（神奈川県） 神奈川県立がんセンター（神奈川県） 横浜南共済病院（神奈川県） 済生会横浜市南部病院（神奈川県） 横浜保土ヶ谷中央病院（神奈川県） 藤沢市民病院（神奈川県） 神奈川県立足柄上病院（神奈川県） 横須賀市立市民病院（神奈川県） 秦野赤十字病院（神奈川県） 藤沢湘南台病院（神奈川県） 以上Yokohama Liver Study Group（YLSG）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 21 Day
Anticipated trial start date	2014 Year 10 Month 24 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	A prospective observational study

Management information
Registered date	2014 Year 10 Month 22 Day
Last modified on	2018 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018012